ActivePhase 3ACTRN12606000361505

Multicentre international study of capecitabine +/- bevacizumab as adjuvant treatment of colorectal cancer

Multicentre international study to evaluate the effects of capecitabine +/- bevacizumab on disease free survival as adjuvant treatment of colorectal cancer


Sponsor

Australiasia Gastro_Intestinal Trial Group (AGITG)

Enrollment

2,152 participants

Start Date

Jun 21, 2007

Study Type

Interventional

Conditions

Summary

This study looks at the effects of the drug capecitabine with or without bevacizumab in the treatment of patients with stage III colorectal cancer. You can join this study if you have cancer of the back passage (rectum) or large bowel (colon). Trial details: Participants will be divided into two groups. One group will receive oral capecitabine (from day 1 to day 14, rest for 7 days then repeat every 3 weekly for a total of 8 cycles), plus intravenous(IV) bevacizumab (one dose on day 1, repeated every 3 weekly for 16 cycles). The other group will receive capecitabine alone (from day 1 to day 14, rest for 7 days then repeat every 3 weekly for a total of 8 cycles), which is standard treatment. New preventative chemotherapies have been developed to reduce the risk of relapse of colorectal cancer. QUASAR2 uses a new combination of an oral chemotherapy drug (capecitabine) and a molecularly targeted therapy (bevacizumab), to determine whether this is more effective and less toxic than capecitabine alone. Colorectal cancer is the most commonly occurring cancer in Australia (excluding non-melanomic skin cancer), and the second most common cancer-related cause of death, responsible for 4,447 deaths in 2003 (1) As many as 40% of patients who undergo potentially curative treatment will ultimately relapse and die of metastatic disease. This observation has led to the development of adjuvant chemotherapies which reduce the risk of relapse. QUASAR2 uses a new combination for adjuvant therapy: an oral chemotherapy drug (capecitabine) and a molecularly targeted therapy (bevacizumab), to define whether this is superior in efficacy and less in toxicity than capecitabine alone, which is a standard of care in this disease.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether adding the targeted drug bevacizumab to capecitabine chemotherapy after surgery improves outcomes for adults aged 18 and over with stage II (high-risk) or stage III colorectal cancer. Participants must have had their tumour completely removed and be fit enough to start treatment within 10 weeks of surgery.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention: Capecitabine 1250mg/m2 orally twice daily(total dose 0f 2500mg/m2) from day 1 to day 14, rest for 7 days then repeat every 3 weekly. Plus Bevacizumab 7.5mg/kg intravenous(IV)_ over 30-

Intervention: Capecitabine 1250mg/m2 orally twice daily(total dose 0f 2500mg/m2) from day 1 to day 14, rest for 7 days then repeat every 3 weekly. Plus Bevacizumab 7.5mg/kg intravenous(IV)_ over 30-90 minutes, one dose on day 1, repeated every 3 weekly for 16 cycles.


Locations(1)

NSW,VIC,QLD,SA,WA,NT,TAS, Australia

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ACTRN12606000361505